Senior Manager, Immunoassay Development

Summary:

Vaxcyte is seeking an accomplished Senior Manager, Immunoassay Developmentto join the CMC Immunoassay group. This role will provide scientific and strategic leadership for the development, qualification, characterization, governance, and lifecycle management of critical reagents and reference materials that support immunoassays across Vaxcyte's vaccine pipeline.

The Senior Manager will combine strong immunoassay technical experience with people leadership, operational discipline, resource planning, study prioritization, timeline management, data review, documentation oversight, and cross-functional coordination. This role will be accountable for ensuring that laboratory activities are planned, staffed, executed, documented, and delivered in alignment with CMC program needs.

Compared with the Staff Scientist role, this position has greater accountability for team management, daily lab execution, staff development, workload balancing, operational readiness, and delivery of assigned workstreams. The Senior Manager is expected to provide hands-on technical support when needed, but the primary accountability is leading people, managing laboratory execution, and ensuring reliable delivery.

Essential Functions:

• Manage daily immunoassay laboratory operations, including study scheduling, staff planning, assay execution oversight, sample and reagent readiness, instrument and workflow coordination, data review, documentation, issue escalation, and operational follow-through.
• Lead, mentor, and manage scientists and research associates responsible for immunoassay development, platform evaluation, method optimization, routine analytical testing, method transfer support, validation readiness, and lifecycle management.
• Assign and prioritize laboratory work based on program needs, staff capability, sample and reagent readiness, timelines, and cross-functional deliverables.
• Provide day-to-day technical and operational oversight to ensure high-quality assay execution, accurate documentation, timely data review, and appropriate escalation of technical or operational risks.
• Support development of fit-for-purpose immunoassays for potency, antigenicity, identity, impurity, characterization, comparability, release, stability, and lifecycle needs across the vaccine pipeline.
• Oversee execution of immunoassay development, optimization, troubleshooting, platform evaluation, routine analytical testing, qualification-support, validation-support, and lifecycle studies.
• Provide hands-on technical support as needed for assay execution, troubleshooting, data interpretation, method optimization, and laboratory readiness.
• Support evaluation of innovative immunoassay platforms and technologies, including ELISA, MSD, bead-based assays, multiplex assays, automation-enabled workflows, and other ligand-binding assay formats.
• Coordinate routine analytical testing within the CMC Immunoassay, including development-stage testing, characterization testing, platform evaluation studies, comparability support, reagent qualification, reference material qualification, and GMP-supporting analytical activities.
• Support immunoassay troubleshooting studies by ensuring clear study design, appropriate resource allocation, disciplined execution, timely data review, and practical follow-up actions.
• Review experimental data, ELN entries, study summaries, technical reports, and documentation to ensure scientific quality, data integrity, and alignment with project objectives.
• Support immunoassay analytical control strategy execution, including critical reagent strategy, reference material strategy, assay controls, system suitability, sample preparation, bridging plans, trending, robustness assessment, and lifecycle monitoring.
• Manage assigned outsourced immunoassay activities with CROs, CDMOs, contract testing laboratories, reagent vendors, and technology partners, including study tracking, communication, data review, timeline management, issue escalation, and deliverable review.
• Partner with ASAT, QC, Quality, Regulatory, Process Development, Manufacturing, Clinical Serology, Program Management, and external partners to support program timelines, method transfer, validation readiness, and long-term lifecycle strategy.
• Develop staff capability through coaching, training, performance feedback, career development, technical guidance, and clear expectations for laboratory execution and documentation.
• Promote a high-performing laboratory culture grounded in scientific rigor, operational discipline, accountability, collaboration, data integrity, documentation quality, safety, and continuous improvement.
• Contribute to technical reports, method development reports, study summaries, platform evaluation summaries, validation-support documents, comparability packages, and regulatory-supporting documentation.
• Support laboratory readiness, including instrument maintenance coordination, reagent and consumable planning, sample tracking, workflow improvement, safety compliance, and good laboratory practices.

Requirements: 

• PHD. in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related discipline is preferred with a minimum of 8 years of relevant biopharmaceutical industry experience; or M.S. in a related discipline with a minimum of 13 years of relevant biopharmaceutical industry experience; or B.S. in a related discipline with a minimum of 16 years of relevant biopharmaceutical industry experience.
• Significant hands-on laboratory experience developing, optimizing, troubleshooting, lifecycle-supporting, and executing immunoassays in vaccine CMC, biologics analytical development, QC, ASAT, or other regulated analytical environments.
• Demonstrated experience leading people, managing laboratory staff, coordinating daily lab operations, assigning work, reviewing data, setting expectations, and supporting staff development.
• Experience managing daily laboratory operations, including staff planning, study planning, testing prioritization, sample and reagent readiness, instrument scheduling, data review, documentation, and technical support.
• Strong technical experience with ligand-binding immunoassay platforms such as ELISA, MSD, electrochemiluminescence-based assays, bead-based assays, multiplex assays, or other relevant immunoassay technologies.
• Experience supporting method development, platform evaluation, method transfer, qualification, validation readiness, routine testing, lifecycle management, and analytical control strategy execution.
• Experience managing multiple laboratory studies, technical workstreams, testing priorities, outsourced activities, timelines, and deliverables in a fast-paced, matrixed environment.
• Experience supporting outsourced immunoassay activities with CROs, CDMOs, contract testing laboratories, reagent vendors, or technology partners is desired.
• Experience working in or supporting GMP-regulated analytical environments is desired.
• Hands-on experience with MSD platforms is highly desirable.
• Hands-on experience with multiplex or other multiplex immunoassay platforms is a plus.
• Direct experience with vaccines, conjugated vaccines, polysaccharide-protein conjugates, multivalent vaccines, or other complex biologics is strongly preferred.
• Strong written and verbal communication skills, with the ability to communicate priorities, technical issues, resource needs, risks, and recommendations clearly across functions.
• Demonstrated ability to build team capability, foster accountability, manage performance, provide technical coaching, and create a collaborative laboratory culture.
• Strong commitment to data integrity, documentation quality, laboratory safety, scientific excellence, accountability, and continuous improvement.

Preferred Qualifications:

• Experience managing or supervising laboratory scientists in analytical development, vaccine CMC, biologics development, QC, ASAT, or related regulated laboratory environments.
• Experience supporting late-stage development, PPQ readiness, BLA preparation, commercial readiness, or lifecycle management of vaccine or biologics programs.
• Experience managing routine analytical testing, method transfer, validation-support activities, bridging, comparability, critical reagent qualification, reference material qualification, and long-term method performance monitoring.
• Experience managing outsourced immunoassay development, validation, platform evaluation, or routine testing activities with external laboratories or technology partners.
• Experience with automation, high-throughput immunoassay workflows, multiplex assay design, LIMS, ELN, and digital data analysis tools.
• Experience helping establish, scale, or operationalize analytical capabilities or laboratory teams within a growing organization.